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Calling on Congress and the Food and Drug Administration (FDA) to limit new regulatory burdens on clinical laboratories, AACC in November released a position statement that urges FDA to limit its proposed laboratory-developed test (LDT) oversight only to high-risk tests, with moderate- and low-risk tests remaining under the existing authority of the Centers for Medicare and Medicaid Services (CMS). Separately, the association is also pushing FDA to withdraw draft guidance documents the agency released on October 3, 2014 and re-issue them through the rulemaking process required under the Administrative Procedures Act. The AACC board of directors visited lawmakers on Capitol Hill on November 21 to explain AACC’s position on LDTs.

“This FDA-proposed action on LDTs is one of the most urgent issues that clinical laboratory professionals currently face,” said AACC President David Koch, PhD, DABCC, FACB. “AACC welcomes dialogue with FDA about how to ensure the quality and safety of laboratory-developed tests. However, regulation that is too burdensome will negatively impact patient care, stifle the progress of innovation, and increase the cost of healthcare.”

Support for Limited FDA Role

AACC’s position statement notes that in 2006 and 2007, FDA issued draft guidance to regulate a narrow subset of LDTs, In Vitro Diagnostic Multivariate Index Assays (IVDMIAs), which AACC supported. But in 2010, FDA reversed this decision and proposed that all LDTs should be subject to FDA oversight. AACC opposes this “one-size-fits-all approach” to regulating LDTs.

While AACC generally supports FDA’s plan to categorize LDTs as high, moderate, and low-risk, the association recommends limiting FDA regulation to joint oversight—with CMS—of the high-risk category. CMS under CLIA subjects LDTs to stringent personnel, quality control, and proficiency testing standards, and requires a laboratory director with an MD or PhD and board-certification to oversee the analytical and clinical validation of all tests developed within a lab.
AACC also recommends that professional laboratory associations collaborate with FDA and other stakeholders to flesh out the criteria for sorting tests within risk categories.

In the position statement, AACC suggests that laboratories should be able to demonstrate clinical validation—a subject on which the FDA has fixated in its draft guidance—through a variety of means, including the use of existing literature review, providing an assessment of patient benefit, or documenting that the test has become standard of care.

Crucially, ensuring patient access to a robust pipeline of LDTs also depends on test innovation. LDTs enable labs to assist physicians in diagnosing rare or new conditions for which no commercial tests exist, such as HIV and SARS when they initially emerged, the position statement notes.

Labs are already under tight regulatory and reimbursement pressure that leaves little room for new policy hurdles, according to Catherine Hammett-Stabler, PhD, DABCC, FACB, a member of the AACC government relations committee and a past president of the association. “The days of labs having four or five platforms or different vendors for routine testing are gone. Most of us have leaned our labs and become more efficient,” she said. “As a result, if your instrument has an open channel and you take advantage of that by putting a product on that open channel, your vendor may not support it, making it an LDT, even though it’s on the automated platform.” Hammett-Stabler is a professor of pathology and laboratory medicine at the University of North Carolina School of Medicine and director of core laboratories at McLendon Clinical Laboratories in Chapel Hill, North Carolina.

Moreover, laboratories depend on many LDTs which cannot be taken for granted as safe under the proposed FDA oversight scheme, Hammett-Stabler emphasized. “I’m concerned that not everyone has recognized that FDA’s proposal could also apply to many tests that we have used for quite some time,” she said. “For example, newborn screening and the follow-up confirmation testing for metabolic disorders using gas chromatography and mass spectrometry, or lamellar body counts using a hematology analyzer—all of those are essentially lab-developed tests with no FDA-cleared products available.”

A More Deliberate Policymaking Process

In a parallel move to the position statement, AACC joined the American Medical Association, American Hospital Association, and 48 other healthcare organizations in requesting that FDA promulgate any new regulations through notice and comment rulemaking rather than finalizing its current guidance documents. Without the rulemaking process, FDA will not have to publicly respond to comments nor conduct an economic impact analysis of the proposal.

“The FDA’s statutory authority to regulate laboratory-developed testing services and the scope of the proposed guidance remains a matter of significant legal controversy,” noted the joint letter to FDA. “While a number of the undersigned organizations do not waive their legal claim that the FDA lacks the statutory authority to regulate laboratory-developed testing services, to the extent that it is established that the FDA does have such authority, all of the undersigned are unanimous that the overwhelming weight of legal authority dictates that the proposed new requirements outlined in the draft guidance must be issued through notice and comment rulemaking.”

The next step in FDA’s own process will be a public meeting January 8 and 9 in Bethesda, Maryland. Hammett-Stabler will give a statement for AACC at this meeting, and she will also serve as AACC’s representative during a panel discussion.

“This FDA-proposed action on LDTs is one of the most urgent issues that clinical laboratory professionals currently face.”

AACC Position on Oversight of Laboratory-Developed Tests
Laboratory-developed tests (LDTs)

LDTs provide timely, accurate quality testing for many conditions for which no commercial test exists or when an existing test does not meet current clinical needs. The regulation of LDTs should remain under CLIA’88 and its deemed accreditation bodies, except for high risk tests that should be subject to both FDA and CMS oversight.